Social-behavioral-educational research (SBER) programs have always faced challenges fitting their work into the parameters of human research protection rules and regulations devised with biomedical research in mind. But the revised Common Rule has produced new issues with informed consent.
“I think the challenge for us as an SBER program is fairly consistent with the challenges we’ve always had in that a lot of changes made are geared toward biomedical types of research, such as the requirement for key information to be put in the beginning of the consent,” says Linda Mayo, CIP, director of the IRB office at the University of New Mexico.
“In the SBER world, we’ve worked really hard to simplify informed consent over the years,” Mayo explains. “We’re usually working with minimalist research. Our template consent form for most survey focus groups and things like that is very brief — less than one page — but it contains all requirements under regulations.”
Mayo and her colleague Jennifer B. Dier, CIP, CCRP, CHRC, senior IRB analyst at the University of California, San Diego, elicited feedback about key information. They found when this requirement was discussed and developed, it was geared toward clinical trials and complicated biomedical consent forms — but not necessarily toward SBER, Mayo says.
“There’s no official guidance on that,” she adds.
Avoid Redundancy
Mayo and Dier studied ways for SBER programs to follow the new key information requirement without producing unnecessary redundancy. For example, an informed consent form for SBER research could be one or two pages. Producing the one-page key information would be just repeating what is easily seen on the regular informed consent document.
“Typically, we say the consent form that goes beyond four pages is a more complicated type of study, and the IRB would need to look to see if the key information page is needed,” Mayo says. “By default, there is flexibility in how institutions implement the requirement.”
Many IRBs use the informed consent document’s length to determine when to apply the key information requirement, she adds.
“If you look at the preamble that talks about the key information, what it says should be included is consent elements one through four,” Mayo says. “It’s meant to make the consent form concise. If you already have a consent form that is one page long, then you’re being pretty concise.”
SBER IRBs can ask principal investigators to make a judgment call based on the institution’s policies. For instance, policy might say, “If your consent is over this length, consider whether the use of a key information section would give your consent more of a summary,” Mayo suggests. “If they send it to the full board, and we think it would benefit from a key information section, then we’ll require it. The key information section is used in a very small percentage of our studies.”
Addiction and substance use studies often use a key information section. “If a study is randomized, that’s where consent forms can benefit from having that summary up front,” Mayo says.
If a study is a clinical trial, includes multiple procedures, or risks that need to be clearly stated, then it probably should use a key information summary.
The University of New Mexico IRB and other institutional IRBs use templates for key information summaries that other IRB professionals can access online. Some key information sections have longer, concise summaries. But the typical key information section contains four or five bullet points, Mayo explains.
FERPA Presents Challenges
Another challenge SBER programs face involves the Family Educational Rights and Privacy Act (FERPA), which requires schools to obtain written permission from the parent or eligible student before they can release any information from student’s educational record, except for certain conditions that are not related to research. (For more information, visit: https://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html.)
“We’ve struggled with the interpretation of getting clinical records,” Mayo says. “When the pandemic hit and things shut down on campus, we had a lot of educational researchers getting signatures in-person. We didn’t have the ability to do that. I had to go back to the registrar and asked for flexibility: Is there a way to get permission under FERPA for a change?” she asks.
IRBs can waive the informed consent signature for research studies, but they cannot waive the FERPA signature, Mayo adds. Instead, the institution received guidance that digital signatures could work.
“They would accept permission for students to access academic records for research by logging into the system and giving digital signatures,” she explains. “That’s brand-new for us.”
This flexibility enabled educational research to continue even as students were not physically in the classroom.
“Previously, we had to have signed permission. Now, the sign-off person says we can do it this way,” Mayo says. “They can continue educational research that uses records, such as maybe faculty are doing pre- and post-survey work and accessing course work.”
Surveys and interviews can be performed remotely. Researchers can obtain electronic permission through FERPA. “Every IRB has a little flexibility in how it can deal with this pandemic,” Mayo notes. “We said, ‘If you are in the middle of data collection and you said you were going to do in-person interviews, and now you have an interview scheduled and you want to do it by Zoom, then just go ahead and do it.’”
If it is minimal risk research, investigators do not need IRB approval. “We’ve had much more flexibility to transition to a more virtual environment,” Mayo says. “It’s important to keep research going. We can’t be a big barrier, especially during this time when important research needs to be done. We’ve had behavioral studies come through on COVID-19. People want to do surveys to see how it’s impacting students because there is less risk of surveying someone online about COVID.”
The SBER IRB’s work has been steady through the pandemic. “We have not seen a loss in studies,” Mayo says. “There was a few-week period where we had quite a few COVID-related studies come through.”
The IRB uses an online submission process with a digital database. It also can hold meetings online, Mayo says.
“We can transition to online, keep up with our workload, and be responsive to the research community,” she adds.
Social-behavioral-educational research programs have always faced challenges fitting their work into the parameters of human research protection rules and regulations devised with biomedical research in mind. But the revised Common Rule has produced new issues with informed consent.
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